Expert opinion on drug safety
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Expert Opin Drug Saf · Jun 2015
ReviewSafety of selective serotonin reuptake inhibitor treatment in recovering stroke patients.
Selective serotonin reuptake inhibitors (SSRIs) are widely used for psychiatric complications after stroke. Studies have indicated additional effects, and SSRIs could potentially be used as enhancers of stroke recovery. However, beneficial effects should be weighed against potential adverse effects. In particular, the possible association with cerebrovascular events has raised concern. ⋯ Evidence suggests that SSRIs may enhance stroke recovery. Most studies on cerebrovascular risk are from non-stroke populations and little is known about recurrent events and mortality post-stroke. In non-stroke populations treatment has been associated with increased risk of intracerebral and intracranial hemorrhage; however the absolute risk is low. The association between SSRIs and ischemic stroke is less clear. Randomized stroke trials indicate that treatment is safe and well tolerated, and the most common side effects are often benign and transient. The trials are small however and not powered to detect potential differences in cerebrovascular events. We await several ongoing large randomized trials before SSRIs can be recommended as a routine pharmacotherapy in stroke recovery.
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Expert Opin Drug Saf · Jun 2015
ReviewSafety of intravenous thrombolysis for acute ischemic stroke in specific conditions.
Intravenous administration of tissue-type plasminogen activator (IV-tPA) remains the only approved therapy that may reverse neurological deficit in patients with acute ischemic stroke (AIS). During the past 20 years, accumulating real-word experience have provided additional information regarding its safety and efficacy in various clinical settings that were originally considered as contraindications for systemic thrombolysis. ⋯ The present narrative review summarizing 20 years of clinical experience with IVT for AIS highlights that many of the current guidelines and protocols should be adjusted to accommodate recent data from registries and real-world experience underscoring the safety of IVT in numerous conditions of AIS that were originally considered as relative or absolute contraindications for administration of IV-tPA.
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Expert Opin Drug Saf · Jun 2015
Review Comparative StudySafety of pembrolizumab for the treatment of melanoma.
The immune checkpoint inhibitor pembrolizumab is the first anti-programmed-death-1 (PD-1) drug licensed by the FDA. It has been approved for the treatment of advanced melanoma, thanks to its positive results in terms of efficacy and its favorable toxicity profile. However, it is not exempt from side effects. In general, these are usually mild and easily manageable but there are pembrolizumab-induced immune-related adverse events (irAEs) that can be severe. Therefore, the understanding, diagnosis and management of those side effects are essential for the optimal care of patients treated with pembrolizumab. ⋯ Pembrolizumab is generally a well-tolerated drug but irAEs are not infrequent. However, these are usually mild and easily manageable in most cases. Early diagnosis and correct management of side effects induced by immune checkpoint inhibitors such as pembrolizumab should be areas of further work in forthcoming years.